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SANCO/11028/2011 Rev. 4 (POOL/E3/2011/11028/110288R4-EN.doc)
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EUROPEAN COMMISSION
Brussels,
C(2011)
rev 4
Draft
COMMISSION IMPLEMENTING REGULATION
of
approving the active substance kresoxym-methyl , in accordance with Regulation (EC)
No 1107/2009 of the European Parliament and of the Council concerning the placing of
plant protection products on the market, and amending the Annex to Implementing
Regulation (EU) No 540/2011
(Text with EEA relevance)
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EN
Draft
COMMISSION IMPLEMENTING REGULATION
of
approving the active substance kresoxym-methyl , in accordance with Regulation (EC)
No 1107/2009 of the European Parliament and of the Council concerning the placing of
plant protection products on the market, and amending the Annex to Implementing
Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the
Council of 21 October 2009 concerning the placing of plant protection products on the market
and repealing Council Directives 79/119/EEC and 91/414/EEC1, and in particular Article
13(2) and Article 78(2) thereof,
Whereas:
(1)
In accordance with Article 80(1)(b) of Regulation (EC) No 1107/2009, Directive
91/414/EEC2 is to apply to active substances listed in Annex I to Commission
Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the
renewal of the inclusion of a first group of active substances in Annex I to Council
Directive 91/414/EEC and establishing the list of those substances3, with respect to the
procedure and the conditions for approval. Kresoxim-methyl is listed in Annex I to
Regulation (EC) No 737/2007.
(2)
The approval of kresoxim-methyl, as set out in Part A of the Annex to Commission
Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No
1107/2009 of the European Parliament and of the Council as regards the list of
approved active substances4, expires on 31 December 2011. A notification was
submitted in accordance with Article 4 of Regulation (EC) No 737/2007 for the
renewal of the inclusion of kresoxim-methyl in Annex I to Directive 91/414/EEC
within the time period provided for in that Article.
(3)
That notification was found to be admissible by Commission Decision 2008/656/EC
of 28 July 2008 on the admissibility of the notifications concerning the renewal of the
1
OJ L 309, 24.11.2009, p. 1.
OJ L 230, 19.8.1991, p. 1.
OJ L 169, 29.6.2007, p. 10.
OJ L 153, 11.6.2011, p.
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inclusion in Annex I to Council Directive 91/414/EEC of the active substances
azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadione and
spiroxamine, and establishing the list of the notifiers concerned5.
(4)
Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the
notifier submitted the data required in accordance with that Article together with an
explanation as regards the relevance of each new study submitted.
(5)
The rapporteur Member State prepared an assessment report in consultation with the
co-rapporteur Member State and submitted it to the European Food Safety Authority
(hereinafter ‘the Authority’) and the Commission. In addition to the assessment of the
active substance, that report includes a list of the studies the rapporteur Member State
relied on for its assessment.
(6)
The Authority communicated the assessment report to the notifier and to the Member
States for comments and forwarded the comments received to the Commission. The
Authority also made the assessment report available to the public.
(7)
At the request of the Commission, the assessment report was peer reviewed by the
Member States and the Authority. The Authority presented its conclusion on the peer
review of the risk assessment of kresoxym-methyl6 to the Commission. The assessment
report and the conclusion of the Authority were reviewed by the Member States and the
Commission within the Standing Committee on the Food Chain and Animal Health
and finalised on 17 June 2011 in the format of the Commission review report for
kresoxim-methyl.
(8)
It has appeared from the various examinations made that plant protection products
containing kresoxim-methyl may be expected to continue to satisfy, in general, the
requirements laid down in Article 5(1) (a) and (b) of Directive 91/414/EEC, in
particular as regards the uses which were examined and detailed in the Commission
review report. It is therefore appropriate to approve kresoxim-methyl.
(9)
In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction
with Article 6 thereof and in the light of current scientific and technical knowledge, it
is, however, necessary to include certain conditions and restrictions not provided for in
the first inclusion in Annex I to Directive 91/414/EEC.
(10)
Without prejudice to the conclusion that kresoxim-methyl should be approved, it is, in
particular, appropriate to require further confirmatory information.
(11)
A reasonable period should be allowed to elapse before approval in order to permit
Member States and interested parties to prepare themselves to meet the new
requirements resulting from the approval.
(12)
Without prejudice to the obligations provided for by Regulation (EC) No 1107/2009 as
a consequence of approval, taking into account the specific situation created by the
transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following
5
OJ L 214, 9.8.2008, p. 70.
European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the
active
substance
kresoxim-methyl.
EFSA
Journal
2010;8(11):1891.
[88
pp.].
doi:10.2903/j.efsa.2010.1891. Available online: www.efsa.europa.eu/efsajournal.htm.
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should, however, apply. Member States should be allowed a period of six months after
approval to review authorisations of plant protection products containing kresoximmethyl.
Member States should, as appropriate, vary, replace or withdraw
authorisations. By way of derogation from that deadline, a longer period should be
provided for the submission and assessment of the update of the complete Annex III
dossier, as set out in Directive 91/414/EEC, of each plant protection product for each
intended use in accordance with the uniform principles.
(13)
The experience gained from inclusions in Annex I to Directive 91/414/EEC of active
substances assessed in the framework of Commission Regulation (EEC) No 3600/92
of 11 December 1992 laying down the detailed rules for the implementation of the first
stage of the programme of work referred to in Article 8(2) of Council Directive
91/414/EEC concerning the placing of plant protection products on the market 7 has
shown that difficulties can arise in interpreting the duties of holders of existing
authorisations in relation to access to data. In order to avoid further difficulties it
therefore appears necessary to clarify the duties of the Member States, especially the
duty to verify that the holder of an authorisation demonstrates access to a dossier
satisfying the requirements of Annex II to that Directive. However, this clarification
does not impose any new obligations on Member States or holders of authorisations
compared to the directives which have been adopted until now amending Annex I to
that Directive or the Regulations approving active substances. In accordance with
Article 13(4) of Regulation (EC) No 1107/2009 the Annex to Implementing
Regulation (EU) No 540/2011 should be amended accordingly.
(14)
In accordance with Article 13(4) of Regulation (EC) No 1107/2009 the Annex to
Implementing Regulation (EU) No 540/2011 should be amended accordingly.
(15)
The measures provided for in this Regulation are in accordance with the opinion of the
Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Approval of active substance
The active substance kresoxym-methyl, as specified in Annex I, is approved subject to the
conditions laid down in that Annex.
Article 2
Re-evaluation of plant protection products
1.
Member States shall in accordance with Regulation (EC) No 1107/2009, where
necessary, amend or withdraw existing authorisations for plant protection products
containing kresoxim-methyl as an active substance by 30 June 2012.
By that date they shall in particular verify that the conditions in Annex I to this
Regulation are met, with the exception of those identified in Part B of the column on
specific provisions of that Annex, and that the holder of the authorisation has, or has
access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC
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OJ L 366, 15.12.1992, p. 10.
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in accordance with the conditions of Article 13(1) to (4) of that Directive and Article
62 of Regulation (EC) No 1107/2009.
2.
By way of derogation from paragraph 1, for each authorised plant protection product
containing kresoxim-methyl as either the only active substance or as one of several
active substances all of which were listed in the Annex to Implementing Regulation
(EU) No 540/2011 by 31 December 2011 at the latest, Member States shall reevaluate the product in accordance with the uniform principles, as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying
the requirements of Annex III to Directive 91/414/EEC and taking into account Part
B of the column on specific provisions of Annex I to this Regulation. On the basis of
that evaluation, they shall determine whether the product satisfies the conditions set
out in Article 29(1) of Regulation (EC) No 1107/2009.
Following that determination Member States shall:
(a)
in the case of a product containing kresoxim-methyl as the only active
substance, where necessary, amend or withdraw the authorisation by 31
December 2015 at the latest; or
(b)
in the case of a product containing kresoxim-methyl as one of several active
substances, where necessary, amend or withdraw the authorisation by 31
December 2015 or by the date fixed for such an amendment or withdrawal in
the respective act or acts which added the relevant substance or substances to
Annex I to Directive 91/414/EEC or approved that substance or substances,
whichever is the latest.
Article 3
Amendments to Implementing Regulation (EU) No 540/2011
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with
Annex II to this Regulation.
Article 4
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in
the Official Journal of the European Union.
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It shall apply from 1 January 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels,
For the Commission
The President
José Manuel BARROSO
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ANNEX I
Conditions of approval as active substance under Regulation (EC) No 1107/2009:
Common Name,
Identification Numbers
Kresoxim-methyl
CAS No 143 390-89-0
CIPAC No 568
IUPAC Name
methyl
(E)methoxyimino[-(otolyloxy)-otolyl]acetate
Purity8
 910 g/kg
Methanol: max. 5
g/kg
Date of
approval
Expiration
of approval
1 January
2012
31 December
2021
Specific provisions
PART A
Only uses as fungicide may be authorised.
PART B
Methyl chloride:
max. 1 g/kg
For the implementation of the uniform principles, as
referred to in Article 29(6) of Regulation (EC) No
1107/2009, the conclusions of the review report on
kresoxim-methyl and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 17 June 2011 shall be
taken into account.
Toluene: max. 1
g/kg
Member States shall pay particular attention to the
protection of groundwater under vulnerable conditions,
the conditions of authorisation shall include, where
appropriate, risk mitigation measures.
The applicant shall submit confirmatory information as
regards:
(1) groundwater exposure risk assessment and in
particular:
– on the lysimeter study to support the statement that the
two unidentified peaks observed do not correspond to
metabolites individually exceeding the trigger value of
0.1 µg/L;
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Further details on identity and specification of active substance are provided in the review report.
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Common Name,
Identification Numbers
IUPAC Name
Purity8
Date of
approval
Expiration
of approval
Specific provisions
– on the recovery of metabolite BF 490-5 in order to
confirm its absence in the lysimeter leachate at levels
exceeding 0.1 µg/L;
– on a groundwater exposure risk assessment for the late
application in apples/ pears and grapes.
The applicant shall submit to the Member States, the
Commission and the Authority the information set out in
point (1) by 31 December 2013.
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ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1)
In Part A, the entry relating to kresoxym-methyl is deleted.
(2)
In Part B, the following entry is added:
“No
8
Common Name,
Identification Numbers
Kresoxim-methyl
CAS No 143 390-89-0
CIPAC No 568
IUPAC Name
methyl
(E)methoxyimino[-(otolyloxy)-otolyl]acetate
Purity9
 910 g/kg
Methanol: max. 5
g/kg
Date of
approval
Expiration
of approval
1 January
2012
31 December
2021
Specific provisions
PART A
Only uses as fungicide may be authorised.
PART B
Methyl chloride:
max. 1 g/kg
For the implementation of the uniform principles, as
referred to in Article 29(6) of Regulation (EC) No
1107/2009, the conclusions of the review report on
kresoxim-methyl and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the
Food Chain and Animal Health on 17 June 2011 shall be
taken into account.
Toluene: max. 1
g/kg
Member States shall pay particular attention to the
protection of groundwater under vulnerable conditions,
the conditions of authorisation shall include, where
appropriate, risk mitigation measures.
The applicant shall submit confirmatory information as
regards:
(1) groundwater exposure risk assessment and in
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Further details on identity and specification of active substance are provided in the review report.
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“No
Common Name,
Identification Numbers
IUPAC Name
Purity9
Date of
approval
Expiration
of approval
Specific provisions
particular:
– on the lysimeter study to support the statement that the
two unidentified peaks observed do not correspond to
metabolites individually exceeding the trigger value of
0.1 µg/L;
– on the recovery of metabolite BF 490-5 in order to
confirm its absence in the lysimeter leachate at levels
exceeding 0.1 µg/L;
– on a groundwater exposure risk assessment for the late
application in apples/ pears and grapes.
The applicant shall submit to the Member States, the
Commission and the Authority the information set out in
point (1) by 31 December 2013. ’
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